
Quality Assurance
4 weeks ago
Overview
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Responsibilities- Lead and facilitate local activities in order to enhance quality in project delivery.
- Works across all BUs in identifying, analyzing, and rectifying systemic quality issues in clinical delivery that are country specific in origin.
- Provides guidance and hands-on support to project teams for CAPA development and tracking.
- Monitor available KPI/Metrics reports across the BUs and identify common tendency/issues for quality improvement at a local level.
- Supports project teams in communicating and managing complex quality issues with the sponsor and/or with sites. Mentor the junior staff members if applicable.
- Engages in identifying the country specific training needs across the BUs and works with global and local stakeholders to provide required solutions.
- Collaborate with global stakeholders in quality related initiatives and activities in order to enhance quality in project delivery at a local level while maintaining compliance with global process.
- Designs and initiates audit/inspection-readiness assessment and improvement plan across all projects, collaborate with global/regional process owners to implements enduring solutions (into training, SOPs/WIs, clinical processes, Trusted Process, etc.) to ensure continuous audit/inspection readiness.
- Works with regional Process Quality Management lead to engage in quality enhancement at a local level.
- BA/BS degree in science or healthcare, or equivalent combined education and experience.
- Moderate clinical research experience in Pharma/CRO/Site Management preferred.
- Knowledge of ICH GCP, JGCP or In-country equivalent required.
- Knowledge of basic project management required.
- Experience of project management in clinical operation preferred.
- Extensive leadership skills preferred. Ability to act independently and proactively on personnel management, customer management, and project management.
- Ability to perform several tasks simultaneously to meet aggressive deadlines.
Drive the quality improvement initiatives of clinical operations aiming at achieving the optimized cross-functional solutions on country specific matters.
Seniority level- Mid-Senior level
- Full-time
- Quality Assurance
- Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
#J-18808-Ljbffr-
Quality Assurance Professional
2 weeks ago
Adelaide, South Australia beBeeInvestigator Full time $60,000 - $90,000Job Title: Quality AssuranceWe are seeking a highly skilled Quality Assurance Officer to join our team. As a key member of our expanding team, you will play a vital role in ensuring the quality of factual investigation reports.The purpose of this role is to support the division and investigators by proofing factual investigation reports in a timely manner....
-
Quality Assurance Assistant
2 weeks ago
Adelaide, South Australia Vivopharm Full timeRDDT, a vivoPharm CompanyGilles Plains SA 5086Science & TechnologyQuality Assurance & ControlvivoPharm, a Vyantbio Company, is a contract research organization supporting thepreclinical research needs of the biotechnology/pharmaceutical sectors. It offers anextensive portfolio of contract services for preclinical drug development and clinicalsupport...
-
Quality Assurance Manager
2 weeks ago
Adelaide, South Australia Persolkelly Full timePERSOLKELLY brings together the legacy and experience of four organisations that shaped the staffing landscape over the past century: Kelly Services, who pioneered the modern temporary help industry in 1946; SKILLED, who crafted the staffing industry in Australia in 1964; Programmed, the leading provider of operations and maintenance services across...
-
Quality Assurance Specialist
2 weeks ago
Adelaide, South Australia beBeeQualityPartner Full time $116,068 - $130,739Job Opportunity:We are seeking a skilled professional to support our centres in assessing compliance and quality, leading fact-finding processes, and building capability through coaching and education.About the Role:Conduct centre visits to assess compliance and quality standards.Lead fact-finding and reporting on critical incidents or complaints.Build...
-
Quality Assurance Expert
2 weeks ago
Adelaide, South Australia beBeeExpertise Full time $90,000 - $100,000Job SummaryWe are seeking a Quality Assurance Expert to join our team. As a Quality Assurance Expert, you will play a crucial role in ensuring the safety and compliance of our devices.About the RoleThis is an excellent opportunity for individuals who want to work in a regulated medical device business and make a significant impact on the quality system.Key...
-
Quality Assurance
4 weeks ago
Adelaide, South Australia Syneos Health Full timeQuality Assurance & Compliance Manager - Melbourne office basedOverviewSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the...
-
Quality Assurance Officer
4 weeks ago
Adelaide, South Australia Davies Stewart Consulting Pty Ltd Full timeQuality Assurance Officer/AdminDavies Stewart is proud to partner with Thermo Fisher Scientific, a global leader in science and innovation, to recruit a dedicated Quality Assurance Officer/Admin on a 68 month contract.This is a fantastic opportunity for someone looking to gain valuable hands-on experience in Quality Assurance while contributing to critical...
-
Quality Assurance Coordinator
2 weeks ago
Adelaide, South Australia Detmold Group Full timeDo you thrive on driving excellence in product and process quality? Detmold Medical is seeking a dedicated Quality Assurance Coordinator to lead quality initiatives across our medical manufacturing operations.This is a fantastic opportunity to play a key role in ensuring compliance and enhancing customer satisfaction in a dynamic Australian owned...
-
Quality Assurance Coordinator
3 weeks ago
Adelaide, South Australia Detmold Group Full timeDo you thrive on driving excellence in product and process quality? Detmold Medical is seeking a dedicated Quality Assurance Coordinator to lead quality initiatives across our medical manufacturing operations. This is a fantastic opportunity to play a key role in ensuring compliance and enhancing customer satisfaction in a dynamic Australian owned...
-
Quality Assurance Coordinator
3 weeks ago
Adelaide, South Australia Detmold Group Full timeDo you thrive on driving excellence in product and process quality? Detmold Medical is seeking a dedicated Quality Assurance Coordinator to lead quality initiatives across our medical manufacturing operations. This is a fantastic opportunity to play a key role in ensuring compliance and enhancing customer satisfaction in a dynamic Australian owned...